DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements filed 03/24/2024, 12/24/2024 and 04/14/2026 have been considered with the exception of a non-patent literature document submitted in the 03/24/2024 statement. The non-patent literature document was not provided and instead a 2-page document containing only an error statement has been provided.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6, 8-16 and 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claims are all within at least one of the four categories of invention, and have been analyzed to determine whether they are directed to a judicial exceptions below.
Step 2A, Prong 1
Each of the claims recites at least one step of instruction for determining/obtaining a total positive end-expiratory pressure, which is grouped as a mental process under 2019 PEG. The claimed limitations involve concepts performed in the human mind, namely observation, evaluation and judgement, which are mental processes under 2019 PEG. Accordingly, each of the claims recites an abstract idea.
Independent claim 1 recites “obtaining an airway pressure and a gas flow rate” (observation) and “obtaining a ventilation volume according to the gas flow rate; and obtaining a total positive end-expiratory pressure, according to a preset respiratory mechanics equation, as well as the airway pressure, the gas flow rate, and the ventilation volume” (judgement or evaluation).
Independent claim 11 recites a device configured to “obtain an airway pressure” and “obtain a gas flow rate” (observation) and “obtain a ventilation volume according to the gas flow rate; and calculate to obtain a total positive end-expiratory pressure, according to a preset respiratory mechanics equation, as well as the airway pressure, the gas flow rate, and the ventilation volume” (judgement or evaluation).
As indicated above the independent claims recite an abstract idea. Further dependent claims 2-6, 8-10, 12-16 and 18-20 merely include limitations that further define the abstract idea (and thus do not make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Step 2A, Prong 2
The above identified abstract idea in independent claims 1 and 11 (and listed dependents) is not integrated into a practical application under 2019 PEG because the additional elements (“medical ventilation device” of claim 1, and “medical device” “pressure sensor” and “flow sensor” of claim 11) either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. Further, the above-mentioned additional elements do not serve to apply the above identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment. Thus, the abstract idea identified above is not integrated into a practical application under 2019 PEG, and the claims are directed to an abstract idea under 2019 PEG.
Step 2B
Claims 1 and 11 does not include additional elements that are sufficient to amount to significantly more than the abstract idea.
Although claim 11 requires the use of a processor, this additional element is a generically claimed computer component which enables the above identified abstract idea to be conducted by performing basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1902-93.
Further, applicant’s specification does not describe any special programming or algorithms required for the processor. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, applicant’s specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts.
The recitation of the CPU amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016); and TLI Communications LLC v. AV Auto, LLC, 823, F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016)
For at least the above reasons, the method of Claims 1-6 and 8-10 and the device of claims 11-16 and 18-20 are directed to applying an abstract idea (e.g., mental process) on a general-purpose computer without (i) improving the performance of the computer, or (ii) providing a technical solution to a problem in a technical field. In other words, none of Claims 1-6, 8-16 and 18-20 provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Therefore, none of claims 1-6, 8-16 and 18-20 amount to significantly more than the abstract idea itself. Accordingly, claims 1-6, 8-16 and 18-20 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme court decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
Examiner notes that claims 7 and 17 are not rejected under 35 U.S.C. 101 as the claims call to utilizing the determined total positive end-expiratory pressure to obtain a recommended value that is used to ventilate the patient based on the recommended value and thus serve to apply the abstract idea to effect a transformation (see step 2A, prong 2 above discussing integration into a practical application).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-9, 11, and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Vicario (US 2019/0374733 A1) in view of Mulqueeny (US 2013/0152934 A1).
Regarding claim 1, Vicario discloses a method for measuring positive end-expiratory pressure (abstract), comprising: obtaining an airway pressure and a gas flow rate (par 0030 disclosing pressure and flow sensors), when a medical ventilation device ventilates a patient (par 0025 disclosing pressure generator #14); obtaining a ventilation volume according to the gas flow rate (par 0034 disclosing multiplying flow by time to determine volume); and obtaining a total positive end-expiratory pressure (par 0034 disclosing determining peep), according to a preset respiratory mechanics equation, as well as the airway pressure, the gas flow rate, and the ventilation volume (see par 0036-0037 disclosing a variety of respiratory mechanics equations).
Vicario is silent to a single respiratory mechanics equations wherein the respiratory mechanics equation is at least constructed from an airway pressure, a gas flow rate, a ventilation volume, and a total positive end-expiratory pressure.
Mulqueeny teaches a similar method for estimating respiratory values utilizing a respiratory mechanics equation that is at least constructed from an airway pressure, a gas flow rate, a ventilation volume, and a total positive end-expiratory pressure (par 0190: airway pressure represented as Paw, gas flow rate represented as V̇, volume represented as V and total positive end expiratory pressure represented as PEEPTOT).
It would have been obvious to utilize the respiratory mechanics equation of Mulqueeny to obtain the total positive end-expiratory pressure in the method of Vicario as doing so allows for a model that accounts for patient effort to be utilized (Mulqueeny: par 0190).
Regarding claim 3, modified Vicario discloses the method of claim 1. Mulqueeny further discloses the respiratory mechanics equation is at least constructed from an airway pressure (par 0190: airway pressure represented as Paw), a pressure generated by respiratory muscle(s) (par 0190: airway pressure represented as Pmus), a gas flow rate (par 0190: gas flow rate represented as V̇), a ventilation volume (par 0190: volume represented by V), and a total positive end-expiratory pressure (par 0190: total positive end expiratory pressure represented as PEEPTOT).
Regarding claim 4, modified Vicario discloses the method of claim 1. Modified Vicario further discloses the medical ventilation device ventilates the patient in a non-invasive ventilation mode (par 0027); wherein the method further comprises: obtaining a gas leakage during non-invasive ventilation; and compensating the gas flow rate based on the gas leakage (Mulqueeny: par 0191 discloses compensating flow for unintentional leak thus disclosing obtaining a gas leakage and compensating the flow based on the leak).
Regarding claim 5, modified Vicario discloses the method of claim 3. Mulqueeny further discloses the pressure generated by respiratory muscle(s) has a preset functional relationship with time (par 0071 disclosing a second order polynomial). Modified Vicario does not expressly disclose this functional relationship being applied in the respiratory mechanics equation. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the pre-set functional relationship in the respiratory mechanics equation in order to determine the PEEP.
Regarding claim 6, modified Vicario discloses the method of claim 5. Mulqueeny further discloses the preset functional relationship comprises an exponential function, a trigonometric function, a piecewise function, or a polynomial function, or combination(s) thereof (par 0071 disclosing a second order polynomial).
Regarding claim 7, modified Vicario discloses the method of claim 1. Vicario further discloses obtaining, according to the total positive end-expiratory pressure, a recommended value (par 0040 disclosing determining a target PEEP), which is used by the medical ventilation device to set a positive end-expiratory pressure (par 0040 disclosing controlling the pressure generator according to the target PEEP); automatically setting the recommended value, so as to enable the medical ventilation device to ventilate the patient based on the recommended value (par 0040 disclosing controlling the pressure generator according to the target PEEP).
Vicario does not expressly disclose displaying the recommended value. However, Vicario does disclose the use of a display system (par 0053 “display screen”) and thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the recommended value be one of the attributes displayed in order to keep a clinician aware of the state of the ventilation/ventilator.
Regarding claim 8, modified Vicario discloses the method of claim 5. Mulqueeny further discloses obtaining a total positive end-expiratory pressure, according to a preset respiratory mechanics equation, as well as the airway pressure, the gas flow rate, and the ventilation volume, comprises: substituting multiple sets of airway pressures, gas flow rates and ventilation volumes at different time points into the preset respiratory mechanics equation, so as to obtain a set of equations for a pressure generated by respiratory muscle(s) and a total positive end-expiratory pressure; and solving the set of equations, so as to obtain the total positive end-expiratory pressure (par 0191 disclosing inputting values and solving the equation over multiple time points).
Regarding claim 9, modified Vicario discloses the method of claim 8. Mulqueeny further discloses the respiratory mechanics equation comprises: PEEPtot=k4*Paw+k1*Pmus-k2*Flow*R-k3*Volume*E (par 0190, wherein k1-k4 are 1 and 1/C is E), wherein, Paw represents the airway pressure (par 0191), Pmus represents the pressure generated by respiratory muscle(s) (par 0191), Flow represents the gas flow rate (par 0191 represented by V̇), Volume represents the ventilation volume (par 0191 represented by V), PEEPtot represents the total positive end-expiratory pressure (par 0191), R represents a viscous resistance of a respiratory system (par 0187), k1, k2, k3 and k4 represent preset empirical coefficients (k1-k4 =1).
Regarding claim 11, Vicario discloses a medical device (#10 fig 1), comprising: a pressure sensor configured to obtain an airway pressure of a patient during a ventilation process (#18 fig 1, par 0030); a flow sensor configured to obtain a gas flow rate of the patient during the ventilation process (#18 fig 1, par 0030); and a processor (#20 fig 1) configured to: obtain the airway pressure of the patient from the pressure sensor (par 0030); obtain the gas flow rate of the patient from the flow sensor (par 0030); obtain a ventilation volume according to the gas flow rate (par 0034 disclosing multiplying flow by time to determine volume); and calculate to obtain a total positive end-expiratory pressure (par 0034 disclosing determining peep), according to a preset respiratory mechanics equation, as well as the airway pressure, the gas flow rate, and the ventilation volume (see par 0036-0037 disclosing a variety of respiratory mechanics equations).
Vicario is silent to a single respiratory mechanics equations wherein the respiratory mechanics equation is at least constructed from an airway pressure, a gas flow rate, a ventilation volume, and a total positive end-expiratory pressure.
Mulqueeny teaches a similar device for estimating respiratory values utilizing a respiratory mechanics equation that is at least constructed from an airway pressure, a gas flow rate, a ventilation volume, and a total positive end-expiratory pressure (par 0190: airway pressure represented as Paw, gas flow rate represented as V̇, volume represented as V and total positive end expiratory pressure represented as PEEPTOT).
It would have been obvious to utilize the respiratory mechanics equation of Mulqueeny to obtain the total positive end-expiratory pressure in the device of Vicario as doing so allows for a model that accounts for patient effort to be utilized (Mulqueeny: par 0190).
Regarding claim 13, modified Vicario discloses the device of claim 11. Mulqueeny further discloses the respiratory mechanics equation is at least constructed from an airway pressure (par 0190: airway pressure represented as Paw), a pressure generated by respiratory muscle(s) (par 0190: airway pressure represented as Pmus), a gas flow rate (par 0190: gas flow rate represented as V̇), a ventilation volume (par 0190: volume represented by V), and a total positive end-expiratory pressure (par 0190: total positive end expiratory pressure represented as PEEPTOT).
Regarding claim 14, modified Vicario discloses the device of claim 11. Modified Vicario further discloses the medical ventilation device ventilates the patient in a non-invasive ventilation mode (par 0027); wherein the method further comprises: obtaining a gas leakage during non-invasive ventilation; and compensating the gas flow rate based on the gas leakage (Mulqueeny: par 0191 discloses compensating flow for unintentional leak thus disclosing obtaining a gas leakage and compensating the flow based on the leak).
Regarding claim 15, modified Vicario discloses the device of claim 13. Mulqueeny further discloses the pressure generated by respiratory muscle(s) has a preset functional relationship with time (par 0071 disclosing a second order polynomial). Modified Vicario does not expressly disclose this functional relationship being applied in the respiratory mechanics equation. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the pre-set functional relationship in the respiratory mechanics equation in order to determine the PEEP.
Regarding claim 16, modified Vicario discloses the device of claim 15. Mulqueeny further discloses the preset functional relationship comprises an exponential function, a trigonometric function, a piecewise function, or a polynomial function, or combination(s) thereof (par 0071 disclosing a second order polynomial).
Regarding claim 17, modified Vicario discloses the device of claim 11. Vicario further discloses obtaining, according to the total positive end-expiratory pressure, a recommended value (par 0040 disclosing determining a target PEEP), which is used by the medical ventilation device to set a positive end-expiratory pressure (par 0040 disclosing controlling the pressure generator according to the target PEEP); automatically setting the recommended value, so as to enable the medical ventilation device to ventilate the patient based on the recommended value (par 0040 disclosing controlling the pressure generator according to the target PEEP).
Vicario does not expressly disclose displaying the recommended value. However, Vicario does disclose the use of a display system (par 0053 “display screen”) and thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the recommended value be one of the attributes displayed in order to keep a clinician aware of the state of the ventilation/ventilator.
Regarding claim 18, modified Vicario discloses the device of claim 15. Mulqueeny further discloses obtaining a total positive end-expiratory pressure, according to a preset respiratory mechanics equation, as well as the airway pressure, the gas flow rate, and the ventilation volume, comprises: substituting multiple sets of airway pressures, gas flow rates and ventilation volumes at different time points into the preset respiratory mechanics equation, so as to obtain a set of equations for a pressure generated by respiratory muscle(s) and a total positive end-expiratory pressure; and solving the set of equations, so as to obtain the total positive end-expiratory pressure (par 0191 disclosing inputting values and solving the equation over multiple time points).
Regarding claim 19, modified Vicario discloses the device of claim 18. Mulqueeny further discloses the respiratory mechanics equation comprises: PEEPtot=k4*Paw+k1*Pmus-k2*Flow*R-k3*Volume*E (par 0190, wherein k1-k4 are 1 and 1/C is E), wherein, Paw represents the airway pressure (par 0191), Pmus represents the pressure generated by respiratory muscle(s) (par 0191), Flow represents the gas flow rate (par 0191 represented by V̇), Volume represents the ventilation volume (par 0191 represented by V), PEEPtot represents the total positive end-expiratory pressure (par 0191), R represents a viscous resistance of a respiratory system (par 0187), k1, k2, k3 and k4 represent preset empirical coefficients (k1-k4 =1).
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over modified Vicario as applied to claims 1 and 11 above, and further in view of Milne (US 2011/0273299 A1).
Regarding claim 2, modified Vicario discloses the method of claim 1. Modified Vicario is silent to obtaining an exogenous positive end-expiratory pressure according to the airway pressure; and obtaining an endogenous positive end-expiratory pressure by subtracting the exogenous positive end-expiratory pressure from the total positive end-expiratory pressure.
Milne teaches a similar respiratory system capable of obtaining an exogenous positive end-expiratory pressure according to the airway pressure; and obtaining an endogenous positive end-expiratory pressure by subtracting the exogenous positive end-expiratory pressure from the total positive end-expiratory pressure (par 0071 disclosing a set PEEP [exogenous PEEP] being subtracted from the measured EEP [total PEEP] in order to obtain the autoPEEP [endogenous PEEP]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine the endogenous and exogenous PEEP as taught by Milne as the endogenous PEEP can be determined and a clinician properly notified when the endogenous PEEP (autopeep) is implicated (Milne: par 0004).
Regarding claim 12, modified Vicario discloses the device of claim 11. Modified Vicario is silent to obtaining an exogenous positive end-expiratory pressure according to the airway pressure; and obtaining an endogenous positive end-expiratory pressure by subtracting the exogenous positive end-expiratory pressure from the total positive end-expiratory pressure.
Milne teaches a similar respiratory system capable of obtaining an exogenous positive end-expiratory pressure according to the airway pressure; and obtaining an endogenous positive end-expiratory pressure by subtracting the exogenous positive end-expiratory pressure from the total positive end-expiratory pressure (par 0071 disclosing a set PEEP [exogenous PEEP] being subtracted from the measured EEP [total PEEP] in order to obtain the autoPEEP [endogenous PEEP]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine the endogenous and exogenous PEEP as taught by Milne as the endogenous PEEP can be determined and a clinician properly notified when the endogenous PEEP (autopeep) is implicated (Milne: par 0004).
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over modified Vicario as applied to claims 9 and 19 above, and further in view of Albanese (US 2017/0367617 A1).
Regarding claim 10, modified Vicario discloses the method of claim 9. Modified Vicario is silent to when calculating the total positive end-expiratory pressure, the method further comprises: for a patient without spontaneous respiration, setting the pressure generated by respiratory muscle(s) to be zero, or setting a corresponding preset empirical coefficient K1 to be zero.
Albanese teaches a similar respiratory system wherein for a patient without spontaneous respiration, setting the pressure generated by respiratory muscle(s) to be zero, or setting a corresponding preset empirical coefficient K1 to be zero (par 0022 “In a passive patient who is not breathing spontaneously, the term Pmus in Equation (1) can be removed” thus disclosing setting either the pressure or the coefficient to 0 in order to remove the pressure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to remove the respiratory muscle pressure from the equation when the patient is not spontaneously respirating in order to increase accuracy as there is not respiratory muscle effort when the patient is non-spontaneously breathing.
Regarding claim 20, modified Vicario discloses the device of claim 19. Modified Vicario is silent to when calculating the total positive end-expiratory pressure, the method further comprises: for a patient without spontaneous respiration, setting the pressure generated by respiratory muscle(s) to be zero, or setting a corresponding preset empirical coefficient K1 to be zero.
Albanese teaches a similar respiratory system wherein for a patient without spontaneous respiration, setting the pressure generated by respiratory muscle(s) to be zero, or setting a corresponding preset empirical coefficient K1 to be zero (par 0022 “In a passive patient who is not breathing spontaneously, the term Pmus in Equation (1) can be removed” thus disclosing setting either the pressure or the coefficient to 0 in order to remove the pressure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to remove the respiratory muscle pressure from the equation when the patient is not spontaneously respirating in order to increase accuracy as there is not respiratory muscle effort when the patient is non-spontaneously breathing.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ranieri US 2008/0234595 A1 discloses a system utilizing a similar respiratory mechanics equation
Sharifi US 2018/0289911 A1 discloses a system where Pmus is represented by a piecewise function
Gholami US 2020/0261674 A1 discloses a system utilizing a similar respiratory mechanics equation
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIRA B DAHER whose telephone number is (571)270-0190. The examiner can normally be reached M-F 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIRA B DAHER/Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
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